Země: Izrael
Jazyk: angličtina
Zdroj: Ministry of Health
METOPROLOL TARTRATE
NOVARTIS ISRAEL LTD
C07AB02
TABLETS SLOW RELEASE
METOPROLOL TARTRATE 200 MG
PER OS
Required
NOVARTIS SAGLIK, GIDA VE TARIM URUNLERI SAN.VE TIC. A.S., TURKEY
METOPROLOL
METOPROLOL
Hypertension, angina pectoris, arrhythmia, prophylaxis of migrain, prophylaxis of reinfarction.
2015-02-28
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986 The medicine is dispensed with a doctor’s prescription only LOPRESOR ® DIVITABS 200 MG SLOW-RELEASE FILM-COATED TABLETS THE ACTIVE INGREDIENT: Each tablet contains: Metoprolol tartrate 200 mg INACTIVE INGREDIENTS: See section 6 “Further information”. READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE. This leaflet contains concise information about the medicine. If you have further questions, refer to the doctor or pharmacist. Keep this leaflet. You may need to read it again. This medicine has been prescribed for the treatment of your ailment. Do not pass it on to others. It may harm them, even if it seems to you that their ailment is similar. 1. WHAT IS THE MEDICINE INTENDED FOR? The medicine is intended for the treatment of hypertension, angina pectoris and irregular heart rate, for the prevention of migraine and for the prevention of recurrent myocardial infarction. Lopresor Divitabs dilates the blood vessels, thereby reducing the blood pressure. THERAPEUTIC GROUP: Beta receptor blockers. 2. BEFORE USING THE MEDICINE X DO NOT USE THE MEDICINE IF: - you are sensitive (allergic) to metoprolol or to any of the additional ingredients contained in the medicine (see section 6 “Further information”) or to any other medicine of the beta receptor blockers group. Some of the symptoms of an allergic reaction can include rash, itching or hives; swelling of the face, lips, tongue or other parts of the body; breathlessness, wheezing or breathing problems. - you have one of the following medical conditions: ∘ asthma, wheezing, difficulty breathing or other severe lung problems, or if you had these problems in the past. ∘ very slow heart rate, lower than 45-50 beats per minute. ∘ low blood pressure. ∘ severe blood vessel disorder that causes poor circulation in the limbs (arms and legs). ∘ a rare tumor of the adrenal gland (pheochromocytoma) that is not being treated with other medicines. ∘ Přečtěte si celý dokument
LOP API 01APR20 New Zealand Data Sheet Jan 2020 1 PRODUCT NAME LOPRESOR ® DIVITABS 200 MG (METOPROLOL TARTRATE) 2 QUALITATIVE AND QUANTITATIVE COMPOSITION The active ingredient is Di-[(±)-1-(isopropylamino)-3-[p-(2-methoxyethyl)phenoxy]-2-propanol] L(+)-tartrate (metoprolol tartrate). Metoprolol is an aryloxypropanolamine derivative. For a full list of excipients, see Section 6.1 List of excipients. 3 PHAMACEUTICAL FORM LOPRESOR ® DIVITABS 200 MG Divitabs slow-release film coated tablets of 200 mg Pale yellow, capsule-shaped, film-coated tablets with biconvex surface and a deep score on both sides. Imprints: “CG/CG” on one side and “CDC/CDC” on other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Hypertension, angina pectoris, arrhythmia, prophylaxis of migraine, prophylaxis of reinfarction. _4.2 DOSAGE AND METHOD OF ADMINISTRATION _ The tablets should be swallowed unchewed with a glass of water. The tablets may be divided in two, if needed. The dosage should be adapted to the requirements of the individual patient. The following dosage recommendations may be taken as a guide: ARRHYTHMIAS 100 to 300 mg daily, given in one to three divided doses. HYPERTENSION The daily oral dose is 100 to 200 mg. 1 of the Divitabs early in the morning; if necessary, another antihypertensive can be prescribed in addition. In mild hypertension, ½ of one of the Divitabs taken early in the morning may suffice. ANGINA PECTORIS The daily oral dose is 100 to 200 mg; if necessary, the daily dose can be increased to 400 mg. LOP API 01APR20 New Zealand Data Sheet Jan 2020 ½ or 1 of the Divitabs early in the morning; if necessary, this dose can be repeated in the evening. MYOCARDIAL INFARCTION Maintenance treatment: The oral maintenance dose is 200 mg daily. The treatment should be continued for at least 3 months. The 200 mg of slow-release preparations (Divitabs) should be taken once daily in the morning. The recommended dosage can be reduced depending on the hemodynamic status of the patient. PREVENTION OF MIGRAINE T Přečtěte si celý dokument